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Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
This study has been completed.
First Received: April 10, 2001   Last Updated: February 6, 2009   History of Changes
Sponsored by: Saint Francis Memorial Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00014092
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.


Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: recombinant interferon alfa
Biological: sargramostim
Drug: temozolomide
Phase II

MedlinePlus related topics: Cancer Melanoma Surgery
Drug Information available for: Interferon alfa-2a Granulocyte-macrophage colony-stimulating factor Temozolomide Aldesleukin Sargramostim Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1999
Detailed Description:

OBJECTIVES:

  • Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa.
  • Determine the safety and tolerability of this regimen in this patient population.
  • Determine the changes in quality of life over time in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.

Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.

Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable stage IV melanoma
  • Measurable metastatic disease
  • No uncontrolled brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN

Renal:

  • BUN no greater than 1.5 times ULN
  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No significant cardiovascular disease

Other:

  • No non-malignant systemic disease
  • No acute infection requiring IV antibiotics
  • No alcohol or substance abuse
  • No other condition, disease, or history of other illness that would preclude study participation
  • No hypersensitivity, allergic reactions, or intolerance to study drugs
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No prior interleukin-2
  • No other concurrent immunotherapy
  • No concurrent investigational vaccines or immunomodulatory agents
  • No other concurrent growth factors

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No prior temozolomide
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • No concurrent steroids (including corticosteroids)

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery

Other:

  • At least 30 days since prior immune-based therapy
  • No concurrent participation in other clinical trials with investigational drugs
  • No other concurrent anticancer drugs
  • No concurrent immunosuppressive therapy
  • No concurrent levamisole or cimetidine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014092

Locations
United States, California
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States, 90404
Saint Francis Memorial Hospital
San Francisco, California, United States, 94109
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Sponsors and Collaborators
Saint Francis Memorial Hospital
Investigators
Study Chair: Lynn E. Spitler, MD Northern California Melanoma Center at St. Francis Memorial Hospital
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067958, SFMH-BB-IND-5301, NCI-V00-1591
Study First Received: April 10, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00014092     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Anti-HIV Agents
Immunologic Factors
Interferons
Angiogenesis Inhibitors
Antiviral Agents
Temozolomide
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Aldesleukin
Anti-Retroviral Agents
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Antineoplastic Agents, Alkylating
Nevus
Interferon Alfa-2a
Alkylating Agents
Interferon Alfa-2b

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Anti-Retroviral Agents
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Angiogenesis Modulating Agents
Growth Inhibitors
Alkylating Agents
Interferon-alpha
Anti-HIV Agents
Neoplasms by Histologic Type
Growth Substances
Interferons
Temozolomide
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Antineoplastic Agents, Alkylating
Interferon Alfa-2a

ClinicalTrials.gov processed this record on May 06, 2009